Kornimate/medical-research-clean huggingface dataset:
relativity study between idiopathic ventricular arrhythmia and sex hormone levels in different stages of menstrual cycle

Conditions: Ventricular Premature Complexes

Summary: the purpose of this study is to determine whether the occurrence of idiopathic right ventricular outflow tract(rvot) arrhythmia is relative to sex hormone levels in different stages of female menstrual cycle

the predilection site of idiopathic ventricular arrhythmia is right ventricular outflow tract ,which is called idiopathic rvot arrhythmia , a retrospective study reported the females are susceptibility to this kind of arrhythmia and another questionaire survey of triggers for rvot-vt initiation indicated that women have rvot-a initiation with recognized states of sex hormonal flux , but few researches were made to study the exact relation between this kind of arrhythmia and sex hormone levels, this is the aim of our study .40 females with regular menses(20 females with rvot arrhythmia ,20 healthy volunteers) will be screened, the participants will undergo ecg monitoring and their blood samples will be collected at various times throughout the study.

Eligibility criteria:
inclusion criteria: * must be female * aged 20 to 45 years, with regular menstrual cycles. * with normal bmi * without organic heart disease * healthy volunteers and women with rvot arrhythmia are both being recruited. exclusion criteria: * pregnancy * use of hormonal therapy including birth control pills or other drugs

Keywords: right ventricular outflow tract arrhythmia sex hormone level menstrual cycle gonadal hormones
ql vs lai for palatoplasty

Conditions: Post-operative Pain; Opioid Use; Cleft Palate

Summary: this study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). the patients will be randomized to receive either a unilateral ql block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. the primary aim will be assessing post-operative pain in the first 48 hours after surgery. secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the ql block or local anesthetic infiltration.


Eligibility criteria:
inclusion criteria * patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest. * ages 6-18 years of age * planned admission post-op * asa status range: 1-3 exclusion criteria * contraindication to ql blocks or lai which may include: * overlying infection skin at the block needle insertion site * coagulopathies * known bleeding disorders * allergy to local anesthetic * cognitive or developmental impairment that would limit ability to report pain. * non-english speaking/writing * subjects or their parent/guardian unable or choose to not give informed consent/assent.
energy balance and breast cancer aspects-ii

Conditions: DCIS Grade 3; Stage I Breast Cancer; Stage II Breast Cancer; LCIS, Lobular Carcinoma in Situ

Summary: the purpose of this study, the ebba-ii trial, is to determine whether a 12 month exercise program comprised of strength and endurance training among newly diagnosed breast cancer patients undergoing adjuvant therapy, will influence cardiopulmonary function. secondary aims are to determine whether the 12 month exercise program will influence factors associated with metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer specific mortality. furthermore, the effect on qol parameters, and dietary factors will be assessed and evaluated.

the ebba (energy balance and breast cancer aspects)-ii study is a randomized clinical 12 month physical activity intervention trial, including female breast cancer patients diagnosed with histologically verified invasive cancer stage i-ii or carcinoma in situ (dcis/lcis) grade 3. * participants are randomized to either control or intervention group 10 days +/- 2 days after surgery. the intervention start 3 weeks after surgery and continue throughout adjuvant treatments given (chemotherapy, radiation, endocrine therapy etc). the intervention group receive a detailed training program based on their own ventilatory maximal oxygen consumption (vo2max) at baseline. they meet for supervised training sessions in groups for 60 minutes x 2/ week during 12 months. in addition, they are informed to exercise at home for at least of total 120 minutes weekly aiming to perform a total of 240 minutes exercise, weekly. the patients in the control group receive standard of care without any restrictions regarding exercise. * all participants will undergo a series of measurements before surgery, after surgery, 6 months and after the 12 months exercise intervention trial. clinical measurements will include anthropometric measurements, fasting blood, fecal and urine samples and cardiopulmonary exercise test (cpet). complete questionnaires (food diary (pfd)/food frequency questionnaires (ffq), quality of life (qol)). * all participants will come to clinical examination and fasting blood sampling after 2, 3, 5 and 10 years follow up.

Eligibility criteria:
inclusion criteria: * age 18-75 years * newly diagnosed dcis grade 3 or invasive breast cancer stage i, ii, histologically verified. * all ethnic groups, but participants have to speak and write the norwegian language. * ability to join and maintain an intervention for 12 months exclusion criteria: * verified heart disease * dysregulated diabetes mellitus or thyroid disorders * muscular and skeletal or other disorders excluding regular physical activity performance * body mass index \>40 kg/m2 * previous surgical treatment for obesity * travel distance \>1.5 hour from home to study site
photobiomodulation on neuropathic pain and sensation post-mastectomy

Conditions: Neuropathic Pain; Sensation Disorders

Summary: the goal of this case study is to examine the effects of photobiomodulation (pbm) on neuropathic pain and sensation post-mastectomy in one female participant. neuropathic pain and somatosensation will be primary measures, along with strength, range of motion testing, and measures of quality of life in response to exposure to pbm for 6 weeks.

the goal of this case study is to examine the effects of photobiomodulation (pbm) on neuropathic pain and sensation post-mastectomy in one female participant. the main question\[s\] it aims to answer are: * will there be a difference in subjective neuropathic pain reported after application of pbm using red and near-infrared wavelengths? * if a difference in symptoms is discovered, how many sessions were administered before such difference was noted? * will there be an observed difference in sensation assessment after application of pbm using red and near-infrared wavelengths? * will there be an observed difference on upper extremity mobility following application of pbm using red and near-infrared wavelengths? * will there be a subjective difference in quality-of-life following application of pbm using red and near-infrared wavelengths? participants will be asked to participate in: 1. initial sensation, range of motion, strength, pain, and quality of life assessments. 2. observation and demonstration of the pbm application with a study investigator present. 3. application of the pbm device to both sides of the chest over the breast tissue for a total of 30 seconds 3 times a week for 6 weeks in the participant's home environment without a study investigator present. 4. documentation of pain and skin observation/sensation after each treatment session. 5. follow-up assessments of sensation, range of motion, strength, pain, and quality of life at the end of week 6 after all pbm treatments have been conducted. 6. weekly monitoring of pain, and skin observation/sensation during weeks 7-10 in the absence of treatment intervention. 7. follow-up telephone calls by a study investigator during weeks 7-10. researchers will compare pre and post assessment results of sensation, pain, range of motion, strength, and quality of life for any changes as a result of the pbm therapy.

Eligibility criteria:
inclusion criteria: * female * status-post mastectomy due to clinical diagnosis of breast cancer * physician approval for participation in study * independent with all mobility * independent with cognitive decision-making exclusion criteria: * active malignancy * active infection
residual plasma concentration of sorafenib and adverse events in chc

Conditions: Advanced or Metastatic Hepatocellular Carcinoma

Summary: to date, sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. however, this treatment causes many adverse effects that may limit its prescription. under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug. currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma. investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis. this study should include 60 patients over an expected duration of 12 months. the aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. the ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.


Eligibility criteria:
inclusion criteria: * major patients. * patients with hepatocellular carcinoma on cirrhosis. * patients treated for the first time with sorafenib for hepatocellular carcinoma. * informed information about the study. exclusion criteria: * patients with contraindications to sorafenib. * pregnant or lactating woman
pharmacological and non-pharmacological interventions in management of venipuncture pain.

Conditions: Child, Hospitalized

Summary: to evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture.

intravenous infusion is a routing practice of drug administration for hospitalized children.however numerous studies have shown that venipuncture is a major source of pain of children during their hospitalization which can lead to moderate to severe pain and cause fear, stress and anxiety in children if there is no effective pain management. the current pain relieving methods include pharmacological (i.e. topical anesthetic) and non-pharmnacological (i.e. distraction techniques) interventions. pharmacological there are scarce evidences supporting that a combination of pharmacological and non-pharmacological interventions can enhance children's abilities in coping with their pain and stress during the venipuncture. emla cream is a main pharmacological intervention in managing needle-related pain which can penetrate the cuticle and epidermal layer of intact skin, enter the dermis where nerve endings are located, and relieve pain. however pharmacological interventions have proven inadequate in mitigating pain and stress.the main non-pharmacological alternatives is distraction techniques. there are extremely limited data studies on merging pharmacological and non-pharmacological interventions to compensate for each other's inadequacies. hence, this study aimed to evaluate the effect of combining both topical anesthetic and distraction techniques in comparison with either of the interventions applied singly. this study adopts a randomized, blind, controlled intervention trial. participants will be randomly assigned to three groups: emla group, distraction group and combined group (emla cream plus distraction techniques). the outcomes will be measured by self-reported pain, parent-reported pain and observer-reported pain. salivary cortisol level will be measured by the ultra sensitive cortisol saliva elisa assay kit. other physiological metrics like heart rate, spo2, and other intravenous cannulation factors will be rated and recorded.

Eligibility criteria:
inclusion criteria: children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization. exclusion criteria: 1. emergency peripheral intravenous puncture. 2. allergic history for lidocaine cream. 3. presence of cognitive impairment, hearing impairment or visual impairment. 4. children who were discharged from the hospital after participating in the experiment but were readmitted due to illness. 5. refuse to participate in the study.

Keywords: children venipuncture related pain and stress emla distraction techniques
dose escalation trial of endoluminal high-dose-rate brachytherapy with concurrent chemotherapy for rectal or anal cancer in patients with recurrent disease or undergoing non-operative management

Conditions: Rectal or Anal Cancer

Summary: the purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus * prior pelvic ebrt * age \> or = to 18 years * ecog performance status 0, 1, or 2 * at least 4 weeks from prior major surgery or radiotherapy * have undergone surgical, medical and radiation oncology evaluations to confirm : * eligible for infusional 5-fu or capecitabine * will not undergo surgery for the study disease * able to receive hdr brachytherapy anc ≥ 1.5 cells/mm3 and plt ≥100,000/mm3 * adequate renal function: creatinine \<1.5 x the upper limit of normal (uln) or calculated creatinine clearance of ≥ 50cc/min * adequate hepatic functions: bilirubin less than 1.5 mg/dl; (except in patients with gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dl) * ast or alt \<3xuln, or \<5x uln if known liver metastases * normal cardiac function: * no active coronary artery disease; * no new york heart association class ii, iii or iv disease; * no arrhythmia requiring treatment * maximum tumor length of 7 cm at time of brachytherapy treatment start exclusion criteria: * women who are pregnant. * women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period and after receipt of brachytherapy. male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy. * patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study. * patients on concurrent anti-cancer therapy other than that allowed in the study. * contraindications to general anesthesia

Keywords: high-dose-rate brachytherapy oral capecitabine infusional 5-fu questionnaires 14-104
acceptance of telemedicine in dermatology patients, physicians and medical staff

Conditions: Dermatologic Disease

Summary: this study is to investigate the current use and intention to use of teledermatology in swiss dermatology patients, dermatologists, other physicians and medical staff.

telemedicine, the use of telecommunication and information technology to provide clinical health care from a distance, has become an increasing role in basic medical care internationally. telemedicine is particularly suitable for skin diseases. in order to improve the use of evidence-based telemedicine, the swiss patients' preferences regarding teledermatology versus face-to-face consultations and the patients' and physicians' determinants of acceptance for teledermatology are investigated in this study. dermatology patients are asked to complete a newly-created 21-items-survey; swiss dermatologists, other physicians and medical staff on telemedicine will complete a similar newly-created, 23-items-questionnaire. a descriptive statistical analysis (e.g. gender, age, place of residence (city or country), waiting time) will be performed.

Eligibility criteria:
inclusion criteria: * patients treated in the department of dermatology of the cantonal hospital aarau and the university hospitals basel and zürich * dermatologists, other physicians and medical staff of the department of dermatology of the cantonal hospital aarau and the university hospitals basel and zürich exclusion criteria: -

Keywords: teledermatology telemedicine
a trial to evaluate the efficacy and safety of formoterol fumarate in the treatment of patients with copd

Conditions: COPD

Summary: the purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.


Eligibility criteria:
inclusion criteria: * medical diagnosis of copd * current or prior history of cigarette smoking exclusion criteria: * medical diagnosis of asthma * chest x-ray diagnostic of significant disease other than copd * significant condition or disease other than copd

Keywords: chronic obstructive pulmonary disease copd formoterol
extended evaluation of deferasirox film-coated tablet (fct) formulation

Conditions: Chronic Iron Overload

Summary: extend evaluation of deferasirox film-coated tablet (fct) formulation

collection of additional safety and efficacy data with deferasirox film-coated tablet (fct) in patients who had completed study cicl670f2201 * provide patients who completed 24 weeks of treatment in the core study, cicl670f2201, the possibility to have additional treatment with the deferasirox fct. * collect additional longer term data on the safety and the tolerability of the deferasirox fct. * collect efficacy data on the deferasirox fct in reduction or maintenance of iron burden as measured by serum ferritin level.

Eligibility criteria:
key inclusion criteria for subjects: * completed 24-weeks of study treatment as described in the core protocol (cicl670f2201). * were deemed to have tolerated deferasirox treatment by the investigator. * provided written informed consent/assent before any study-specific procedures were performed. for pediatric patients, consent was obtained from parent(s) or legal patient's representative. investigators were to have also obtained assent of patients according to local, regional or national guidelines. key exclusion for subjects: the exclusion criteria followed those described for the core protocol cicl670f2201, which were as follows: * creatinine clearance below the contraindication limit in the locally approved prescribing information. * serum creatinine \> 1.5 × upper limit of normal range (uln) at screening * alanine aminotransferase (alt)/serum glutamic pyruvic transaminase (sgpt) \> 5 × uln, * significant proteinuria * patients with significant impaired gastrointestinal function or gastrointestinal disease * clinical or laboratory evidence of active hepatitis b or hepatitis c * patients with psychiatric or addictive disorders * patients with a known history of hiv seropositivity (elisa or western blot). * history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. * patients with a history of hypersensitivity to any of the study drug or excipients. * patients with significant medical condition that could interfere with the ability to participate in this study * patients who were participating in another clinical trial or receiving an investigational drug. * patients using prohibited medication, * patients with liver disease with severity of child-pugh class b or c. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment

Keywords: adult pediatric, anemia. myelodysplastic syndrome thalassemia film coated tablet icl670 mds chelation deferasirox iron overload
7 cm vs. 5 cm pancreatic stents for the prevention of post-ercp pancreatitis in high-risk patients

Conditions: Post-ERCP Acute Pancreatitis

Summary: acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ercp). the incidence of post-ercp pancreatitis (pep) is estimated to be 10% to 15% in high-risk patients. current guidelines recommend using pancreatic duct stent (pds) for pep prevention in high-risk patients, but it is not clear whether stent length will affect the effect of pep prevention. the longer pds will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for pep. findings from two retrospective studies showed that longer pds was more effective in reducing the risk of post-ercp hyperamylasemia and the frequency of pep compared with the shorter pds. we conducted this trial to test whether 7cm pds was superior to 5cm pds in pep prevention in high-risk patients.


Eligibility criteria:
inclusion criteria: 1. un-intentional pancreatic duct cannulation: * 2 or more times; * 1 time with more than 10 minutes cannulation. 2. double-wire technique; 3. high-risk patients: met at least 1 of the major criteria * clinical suspicion of sphincter of oddi dysfunction; * pancreatic sphincterotomy * delayed precut sphincterotomy * ≥ 8 cannulation attempts * pneumatic dilatation of an intact biliary sphincter * ampullectomy or met at least 2 or more of the minor criteria * age \< 50; * female; * normal tbil; * ≥ 3 injections of contrast into the pancreatic duct with ≥ 1 injection to the tail of the pancreas; exclusion criteria: * therapeutic pds; * acute pancreatitis within 3 days; * with a history of pancreatic surgery or biliary-enteric anastomosis; * pregnant or breastfeeding women; * unwilling or inability to provide consent.

Keywords: ercp pep post-ercp pancreatitis pancreatic duct stent